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About Lisata Therapeutics Inc.
Lisata Therapeutics Inc. (Nasdaq: LSTA) is a clinical-stage pharmaceutical company headquartered in Basking Ridge, New Jersey. The company is dedicated to the discovery, development, and commercialization of innovative therapies aimed at addressing advanced solid tumors and other major diseases. Lisata leverages its proprietary CendR Platform® technology to enhance the delivery and efficacy of anti-cancer therapies, positioning itself as a key innovator in the biopharmaceutical landscape.
Core Product and Mechanism of Action
Lisata's lead product candidate, certepetide (formerly LSTA1), is an investigational cyclic peptide designed to activate a novel tumor-specific uptake pathway known as the C-end rule (CendR) mechanism. This unique pathway enhances the penetration and accumulation of co-administered or tethered anti-cancer drugs within solid tumors. Beyond improving drug delivery, certepetide modifies the tumor microenvironment by reducing its immunosuppressive nature and promoting immune cell infiltration, thereby increasing the efficacy of immunotherapies and chemotherapy regimens.
Clinical Development and Pipeline
Lisata is conducting multiple clinical trials across various cancer types, including pancreatic ductal adenocarcinoma (PDAC), cholangiocarcinoma, melanoma, glioblastoma, and other solid tumors. Key trials include:
- ASCEND Trial: A Phase 2 study evaluating certepetide with standard-of-care chemotherapy for metastatic pancreatic cancer.
- BOLSTER Trial: A Phase 2a double-blind trial assessing certepetide in combination with chemotherapy and immunotherapy for cholangiocarcinoma.
- CENDIFOX Trial: A Phase 1b/2a study investigating certepetide in neoadjuvant settings for pancreatic, colon, and appendiceal cancers.
- iLSTA Trial: A Phase 1b/2a trial examining certepetide with chemotherapy and immunotherapy for locally advanced non-resectable pancreatic cancer.
These trials aim to validate certepetide's ability to enhance treatment outcomes across a spectrum of solid tumors.
Strategic Partnerships and Collaborations
Lisata has established notable research and development collaborations to expand the applications of its technology. Key partnerships include:
- Collaboration with Valo Therapeutics to explore certepetide's synergy with immunotherapy platforms like PeptiCRAd.
- Partnership with Kuva Labs to integrate certepetide into advanced cancer diagnostic technologies.
- Research agreement with the University of Cincinnati to evaluate certepetide for non-oncology applications like endometriosis.
These collaborations highlight Lisata's commitment to innovation and its technology's versatility.
Regulatory Designations and Market Position
Certepetide has received multiple regulatory designations, including Fast Track and Orphan Drug Designations from the U.S. FDA and the European Union for indications such as pancreatic cancer, glioma, osteosarcoma, and cholangiocarcinoma. These designations underscore the potential of certepetide to address unmet medical needs in rare and aggressive cancers.
Business Model and Revenue Potential
Lisata operates on a business model centered around clinical innovation, strategic partnerships, and intellectual property development. The company generates value through licensing agreements, milestone payments, and potential future commercialization of its therapies. Its robust pipeline and proprietary technology platform provide a strong foundation for long-term growth in the oncology market.
Challenges and Competitive Landscape
As a clinical-stage company, Lisata faces challenges typical of the biopharmaceutical industry, including regulatory hurdles, high R&D costs, and competition from established players and emerging startups. However, its focus on solid tumors—a segment with significant unmet needs—provides a competitive edge. By combining innovative technology with strategic collaborations, Lisata aims to differentiate itself in a crowded market.
Conclusion
Lisata Therapeutics Inc. is at the forefront of developing next-generation cancer therapies. Its lead product, certepetide, and the underlying CendR Platform® technology represent significant advancements in targeted drug delivery and tumor microenvironment modification. With a strong clinical pipeline, strategic partnerships, and regulatory endorsements, Lisata is well-positioned to make a meaningful impact in oncology and beyond.
Lisata Therapeutics (Nasdaq: LSTA), a clinical-stage pharmaceutical company, has secured $2.2 million in non-dilutive funding through New Jersey's Technology Business Tax Certificate Transfer Program. This funding allows Lisata to convert state net operating losses into working capital, which will enhance their clinical development initiatives. Over the past four years, Lisata has received nearly $18 million through this program. The company is focused on advancing its therapeutic candidate, LSTA1, designed to improve the delivery of anti-cancer drugs to solid tumors. LSTA1 has shown promising results in clinical trials, particularly for pancreatic cancer, and may enhance the efficacy of various cancer treatments while minimizing side effects on normal tissues.
Lisata Therapeutics, a clinical-stage pharmaceutical company focused on innovative therapies for advanced solid tumors, will participate in the Sequire Investor Summit from April 24-26, 2023, at La Concha Resort in San Juan, Puerto Rico. CEO David J. Mazzo will present a company overview on April 25 at 3:00 PM. The event aims to connect emerging companies with investors.
Lisata's lead investigational product, LSTA1, targets novel uptake pathways for anti-cancer drugs, enhancing their delivery to tumors while sparing normal tissues. It has shown favorable safety and activity in clinical trials for pancreatic cancer, and has potential for various treatment modalities, including immunotherapies. The company continues to gather data to support LSTA1's effectiveness against a range of solid tumors.
Lisata Therapeutics (LSTA) has initiated the iLSTA Trial, a pivotal study evaluating its investigational drug LSTA1 in combination with standard chemotherapy and immunotherapy for locally advanced pancreatic ductal adenocarcinoma (PDAC). Conducted in Australia, this trial aims to treat 30 patients and assess safety and pharmacodynamics. WARPNINE will manage the trial, providing funding and recruitment support, while Lisata supplies the drug and regulatory assistance. LSTA1 is designed to enhance drug delivery to tumors, potentially improving treatment outcomes for patients with this challenging cancer. Positive early results could signify a major breakthrough in pancreatic cancer therapy.
Lisata Therapeutics, Inc. (Nasdaq: LSTA) reported its 2022 financial results and a business update, highlighting significant clinical developments in its drug pipeline. The lead candidate, LSTA1, is advancing in global studies for solid tumors, showing promise in enhancing delivery of anti-cancer drugs. HONEDRA® is in pre-consultation for registration in Japan, while XOWNA® faces enrollment challenges due to COVID-19 impacts. Financially, the company saw a 26% decrease in R&D expenses for the year, totaling $13.1 million, and experienced net losses of $54.2 million. As of December 31, 2022, Lisata had $69.2 million in cash, projected to sustain operations through mid-2025.
Lisata Therapeutics, Inc. (Nasdaq: LSTA) announced it will report its financial results for Q4 and FY 2022 on March 30, 2023, post-market. The conference call will start at 4:30 p.m. ET, with a new registration process for participants. Lisata is a clinical-stage company focused on developing innovative therapies for advanced solid tumors. Its lead product, LSTA1, aims to enhance the delivery of anti-cancer drugs to tumors while sparing normal tissues, showing promising results in pancreatic cancer trials. Lisata continues to explore LSTA1 for various solid tumors, alongside its autologous CD34+ cell therapy technology.
Lisata Therapeutics (Nasdaq: LSTA) announced its participation in two major investor conferences. The first event is the 2023 BIO CEO & Investor Conference in New York, scheduled for February 6-9, 2023, where CEO David J. Mazzo will present on February 7. The second event is Biocom California’s 13th Annual Global Life Science Partnering & Investor Conference in La Jolla, taking place from February 28 to March 2, 2023, with President David S. Slack presenting on March 1. These conferences will include one-on-one investor meetings. Lisata focuses on innovative therapies for advanced tumors, with its lead candidate, LSTA1, showing promise in enhancing drug delivery for pancreatic cancer.
Lisata Therapeutics (LSTA) reported its Q3 2022 financial results, showing significant advancements in its clinical pipeline post-merger. The company is actively conducting Phase 1b/2 studies of LSTA1 in China, Australia/New Zealand, and the U.S., with preliminary data expected in late 2023 and 2024. Research and development expenses decreased to $3.4 million, while net losses rose to $37.4 million. The company has approximately $75.5 million in cash, cash equivalents, and securities, positioning it for future trials and strategic partnerships.
BASKING RIDGE, N.J., Nov. 7, 2022 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) announced participation in key upcoming events. These include the RNA at the Bench and Bedside III from November 8-10 in Carlsbad, CA, with David Slack attending one-on-one meetings. They will also present at the Inv€$tival Showcase 2022 on November 14 in London, with David J. Mazzo presenting a corporate overview at 2:30 p.m. GMT. Lastly, management will engage in one-on-one meetings at the Jefferies London Healthcare Conference from November 15-17, also in London.
Lisata Therapeutics, a clinical-stage pharmaceutical company, will announce its financial results for Q3 2022 on November 10, 2022, at 4:30 p.m. (ET). The company is focused on developing therapies for advanced solid tumors. Its lead product, LSTA1, aims to enhance the delivery of anti-cancer drugs by modifying the tumor microenvironment. Clinical trials have shown LSTA1 to be safe and effective for pancreatic cancer treatment. Lisata’s technology platform also supports autologous CD34+ cell therapy programs.
Lisata Therapeutics (Nasdaq: LSTA) announced its participation in two significant events: the RNA USA Leaders Congress on October 18-19, 2022, where David S. Slack will join a keynote panel, and the LD Micro Main Event XV Conference on October 25-27, 2022, featuring a presentation by CEO David J. Mazzo. Lisata is focused on developing therapies for advanced solid tumors, with its lead candidate LSTA1 showing promise in enhancing chemotherapy delivery for pancreatic cancer. The company also investigates other therapies through its CD34+ cell technology platform.
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